SEEK

Device, Caries Detection

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Seek.

Pre-market Notification Details

• Device ID: K953526
• 510k Number: K953526
• Device Name: SEEK
• Classification: Device, Caries Detection
• Applicant: ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Contact: L. M. Chatwin
• Correspondent: L. M. Chatwin; ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Product Code: LFC
• CFR Regulation Number: 872.1740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-27
• Decision Date: 1995-09-05